PHS 2017-2, Omnibus Solicitation for SBIR/STTR Grant ApplicationsJune, 2017
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESPHS 2017-2
OMNIBUS SOLICITATION OF THE
NATIONAL INSTITUTES OF HEALTH,
CENTERS FOR DISEASE CONTROL AND PREVENTION, AND
FOOD AND DRUG ADMINISTRATIONFOR
SMALL BUSINESS INNOVATION
RESEARCH (SBIR)
AND
SMALL BUSINESS TECHNOLOGY TRANSFER (STTR)
GRANT APPLICATIONS
NIH, CDC, and FDA Program Descriptions and
Research Topics
Submission Dates
September 5, 2017, and January 5, 2018***
National Institutes of Health (SBIR and STTR)
Centers for Disease Control and Prevention(SBIR)
Food and Drug Administration (SBIR)
***This FOA is being issued with limited due dates to accommodate the transition from FORMS-D to FORMS-E application packages. This FOA will be reissued for additional due date(s) on or after January 25, 2018.***
HHS expects to re-issue these Omnibus after the January 5, 2018 due date.
TABLE OF CONTENTS
NIH, CDC, AND FDA Program Descriptions and Research Topics
NATIONAL INSTITUTES OF HEALTH (NIH)
Trans-NIH Research Programs
Phase IIB Competing Renewal Awards
Research Supplements to Promote Diversity in Health-Related Research
Technical Assistance Programs (Subject to Change)
Niche Assessment Program
Commercialization Accelerator Program (CAP)
National Institute on Aging (NIA)
Phase IIB Competing Renewal Awards
Division of Behavioral and Social Research (DBSR)
Division of Aging Biology (DAB)
Division of Neuroscience (DN)
Division of Geriatrics and Clinical Gerontology (DGCG)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Limited Amount of Award
Phase IIB Competing Renewal Awards
Medications Development
Technological Methods for the Treatment of Hazardous Drinking and Alcohol Use Disorders
Prevention
Improving the Delivery of Alcohol Treatment Services
Fetal Alcohol Spectrum Disorder (FASD) and Alcohol-Related Birth Defects
Development of Clinical Biomarkers of Alcohol Exposure and Alcohol-Induced Organ Damage
Alcohol Biosensors
Alcohol Use and HIV Infection, and HIV Co-infection with HCV, HBV, or TB
Electronic Diagnostic Clinical Assessment of Frailty among HIV+ Individuals with Past and/or Current Alcohol Use Disorders: Severity and Patterns
Monitoring Alcohol Use among HIV+ Patients
Stem Cell Research for Alcohol-induced Disorders
Role of Non-coding RNAs in the Neuroadaptation to Alcoholism
In vivo Detection of Neuromodulators in Behaving Animals
Ex vivo Efficacy Screens to Identify Pharmacotherapies for Alcohol Dependence
Develop Network Pharmacology Strategy for Preclinical Medication Development
Novel Tools and Technologies to Detect the Effects of Alcohol on the CNS Structure and Activities
Research Tools
Roadside Driver Tests to Detect Marijuana or Other Drug Use Immediately Before Driving
Other Research Topic(s) Within the Mission of the Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Limited Total Amounts for Phase I and Phase II Awards
Division of AIDS
Division of Allergy, Immunology, and Transplantation
Division of Microbiology and Infectious Diseases
Other Research Topic(s) Within the Mission of the Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Limited Amount of Award
Arthritis and Musculoskeletal and Skin Diseases
Special Emphasis Areas of Interest to Small Businesses:
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Cancer Institute (NCI)
Major NCI SBIR/STTR Portfolio Areas:
Limited Amount of Award
Phase IIB SBIR Competing Renewal Awards
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Budget Guidelines
Phase IIB Competing Renewal Awards
NICHD Topic Areas
Other Research Topic(s) Within the Mission of the Institute
National Institute on Drug Abuse (NIDA)
Special Features of NIDA SBIR Program
High Programmatic Priority Research Topics
Research Topics by Division
National Institute on Deafness and Other Communication Disorders (NIDCD)
Limited Amount of Award
Phase IIB Competing Renewal Awards
Hearing and Balance Program
Voice, Speech, and Language Programs
Taste and Smell Program
Other Research Topic(s) Within the Mission of the Institute
National Institute of Dental and Craniofacial Research (NIDCR)
Developmental Biology and Mammalian Genetics
Infectious Diseases and Immunity
Preclinical Research
Clinical Research
Oral, Oropharyngeal and Salivary Gland Cancers
Temporomandibular Disorders and Orofacial Pain
Saliva, Salivary Diagnostics, and Salivary Gland Diseases
Biotechnology, Biomaterials, and Applications for Regeneration and Restoration of Oral, Dental and Craniofacial Tissues
Clinical and Behavioral Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Limited Amount of Award
Clinical Trials
Phase IIB Competing Renewal Awards
Final Progress Reports
Additional Programs and Services for NIDDK SBIR/STTR Awardees
Diabetes, Endocrinology and Metabolic Diseases
Digestive Diseases and Nutrition
Kidney, Urologic and Hematologic Diseases
Other Research Topic(s) Within the Mission of the Institute
National Institute of Environmental Health Sciences (NIEHS)
Exposure Assessment Tools
Nano Environmental Health and Safety
Toxicity Screening, Testing, and Modeling
Biomarkers
Education/Outreach
Hazardous Substances Remediation and Site Characterization SBIR Program
Worker Training Program
National Eye Institute (NEI)
Limited Amount of Award
Phase IIB Competing Renewal Awards
General Research and Development Topics
Specific Research and Development Topics
Additional Information
National Institute of General Medical Sciences (NIGMS)
National Heart, Lung, and Blood Institute (NHLBI)
Cardiovascular Sciences
Lung Diseases
Blood Diseases and Resources
Center for Translation Research and Implementation Science
Phase II Applications
NHLBI-Supported Funding Opportunity Announcements (FOAs)
Phase IIB Competing Renewal Awards
Limited Amount of Award
Final Progress Reports
Programs and Services for NHLBI Small Business Awardees
National Human Genome Research Institute (NHGRI)
National Institute of Mental Health (NIMH)
Phase IIB Competing Renewal Awards
Division of Neuroscience and Basic Behavioral Science (DNBBS)
Division of Translational Research (DTR)
Division of AIDS Research (DAR)
Division of Services and Intervention Research (DSIR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Neurological Disorders and Stroke (NINDS)
Limited Amount of Award and Budget Waivers
Phase IIB Competing Renewal Awards
General Areas of Interest
Translational Research
Clinical Trials
Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative
Countermeasures Against Chemical Threats
National Institute of Nursing Research (NINR)
1. ResearchandDevelopmentofTechnologiesforAssessment and Managementof Symptoms
2. Research and Development of Technologies to Enhance Self-Management and Clinical Care
3. Researchand Development of Technologies for Health Promotion and Disease Prevention
4. Research and Development of Technologies for End-of-Life and Palliative Care
National Center For Advancing Translational Sciences (NCATS)
Limited Amount of Award
Phase IIB Competing Renewal Awards
Topics of interest to NCATS– Grant Funding Opportunities
National Center for Complementary and Integrative Health (NCCIH)
Topics of Interest to NCCIH
Topics That Are of Less Interest to NCCIH
Other Research Topic(s) Within the Mission of the Center
National Library of Medicine (NLM)
Other Research Topic(s) Within the Mission of the Center
Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of Research Infrastructure Programs (ORIP)
Phase IIB Competing Renewal Awards
Research Topics of Interest to ORIP
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
Center For Global Health (CGH)
(1) Portable Multi-function System for Assessing NTD Program Impact
National Center on Birth Defects and Developmental Disabilities (NCBDDD)
(2) Technology-Assisted In-Office Screening for Mental, Emotional and Behavioral Disorders in Pediatric Practices
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)
(3) Food Service Guidelines Algorithmic Database Processing and ID Tool
(4) Innovative Approaches for Maternal and Infant Safety in Maternity Hospitals
(5) Population Health Data Using Blockchain Technology
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
(6) Antibiotic Resistant Healthcare-Associate Infections
(7) Detection, Transmission, Ecology, and Prevention of Antimicrobial Resistance in Enteric Bacteria
(8) Rapid Diagnostic Test for Candida species Identification and Multidrug Resistance Profiling
(9) Vector Borne Diseases: Detection, Prevention, Diagnosis and Response
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
(10) Improved Diagnostic Tests for HIV, STDs, Hepatitis and TB
National Center for Immunization and Respiratory Diseases (NCIRD)
(11) Prevention and Diagnosis of Acute Respiratory Infections in the US and Globally
National Center for Injury Prevention and Control (NCIPC)
(12) Improving Platforms for Data Linkage in Drug Overdose Prevention
(13) Innovations to Reduce Motor Vehicle-Related Deaths and Injuries
(14) Innovative Technology or Media to Prevent Violence
(15) Technological Tools for Monitoring Children’s Symptoms after Traumatic Brain Injury
National Institute for Occupational Safety and Health (NIOSH)
(16) Control Technology and Personal Protective Equipment for High Risk Occupations
(17) Exposure Assessment Methods for High Risk Occupations
(18) Work-related Injuries from Motor Vehicle Crashes
FOOD AND DRUG ADMINISTRATION (FDA)
Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)
Center for Food Safety and Applied Nutrition (CFSAN)
Center for Devices and Radiological Health (CDRH)
Center for Veterinary Medicine (CVM)
Office of Critical Path Programs
Office of Orphan Products Development
Other Research Topic(s) Within the Mission of FDA
APPENDIX A: National Institutes of Health SBA-Approved SBIR/STTR Topics for Awards over Statutory Budget Limitations
National Cancer Institute (NCI)
National Center For Advancing Translational Sciences (NCATS)
National Center for Complementary and Integrative Health (NCCih)
National Eye Institute (NEI)
General Research and Development Topics
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
A.Research and development for biomedical technologies (medical devices, diagnostic instruments, pharmaceuticals, drugs, therapeutics, vaccines, and biologics) that require clearance by the FDA as a regulated product before commercial distribution.
National Institute of Dental and Craniofacial Research (NIDCR)
Infectious Diseases and Immunity
Preclinical Research
A.Preclinical research and development activities for dental and craniofacial technologies (including devices, diagnostic instruments, reconstructive materials, pharmaceuticals, therapeutics, vaccines and biologics) that require review and approval by the FDA as a regulated product before commercial distribution.
Clinical Research
Saliva, Salivary Diagnostics, and Salivary Gland Diseases
Biotechnology, Biomaterials, and Applications for Regeneration and Restoration of Oral, Dental and Craniofacial Tissues
Clinical and Behavioral Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
Division of Cell Biology and Biophysics
Division of Genetics and Developmental Biology
Division of Pharmacology, Physiology, and Biological Chemistry
Division of Biomedical Technology, Bioinformatics, and Computational Biology
Division of Training, Workforce Development, and Diversity
A.Development of products or services to enhance diversity of the scientific workforce.
Center for Research Capacity Building
National Institute of Mental Health (NIMH)
Division of Neuroscience and Basic Behavioral Science (DNBBS)
Division of AIDS Research (DAR)
Division of Services and Intervention Research (DSIR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Library of medicine (nlm)
Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of Research Infrastructure Programs (ORIP)
Funding Opportunity Announcements, Application Instructions, and Appendices are contained in separate files. Follow the links below to view these documents.
Funding Opportunity Announcements
REMINDER: ALL APPLICATIONS MUST BE SUBMITTED IN RESPONSE TO A FUNDING OPPORTUNITY ANNOUNCEMENT THROUGH GRANTS.GOV
Small Business Innovation Research Program Parent Announcement (SBIR [R43/R44])
Small Business Technology Transfer Program Parent Announcement (STTR [R41/R42])
Additional Special Announcements for Small Business Research Opportunities
Application Instructions
SF424 (R&R) Application INSTRUCTIONS and Electronic Submission Information ()
Appendices
STTR Model Agreement (MS Word)
Extramural Invention Reporting Compliance Responsibilties
()
NIH, CDC, and FDA Program Descriptions and Research Topics1
PHS 2017-2, Omnibus Solicitation for SBIR/STTR Grant ApplicationsJune, 2017
PROGRAM DESCRIPTIONS AND RESEARCH GRANT TOPICS
The research topics shown in this solicitation represent program areas that may be of interest to applicant small business concerns in the development of projects that have potential for commercialization. Small business concerns are encouraged to submit SBIR/STTR grant applications in these areas.
APPLICABLE TO NIH ONLY: SBIR and STTR grant applications will be accepted and considered in any area within the mission of the awarding components (i.e., Institutes and Centers (ICs)) identified in this solicitation.
Applicants are strongly encouraged to subscribe to the NIH Guide for Grants and Contracts LISTSERV ( or query program administrators periodically via email to learn of new or emerging scientific interests of the NIH, CDC, and FDA awarding components.
You may also subscribe to the SBIR-STTR LISTSERV list to get timely information about the NIH SBIR/STTR Programs (
Additional information on each of the awarding components (ICs) and their research interests is available electronically on the home pages shown throughout the “Research Topics” section of the solicitation.
The Fogarty International Center, which provides support only for conferences, postdoctoral fellowships for research in the United States and abroad, and senior scientist exchanges between the United States and other countries, does not participate in the SBIR/STTR program.
NATIONAL INSTITUTES OF HEALTH (NIH)
NIH is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability.
The goals of the agency are as follows:
1.to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health;
2.to develop, maintain, and renew scientific human and physical resources that will assure the Nation's capability to prevent disease;
3.to expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research; and
4.to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.
In realizing these goals, the NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research:
- in the causes, diagnosis, prevention, and cure of human diseases;
- in the processes of human growth and development;
- in the biological effects of environmental contaminants;
- in the understanding of mental, addictive and physical disorders; and
- in directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists.
In addition, the NIH sponsors training of research personnel; career development of new and established scientists; construction and renovation of research facilities and provision of other research resources.
To carry out these responsibilities, the NIH is organized into awarding components (Institutes/Centers). Those components that have an extramural element, that is, those that provide funds for research and research training activities in organizations external to the NIH, are shown below. The NIH makes every effort to finance worthy applications, including the co-funding of such applications by one or more awarding components having relevance in the projects.
Funding levels for projects are determined through the combined interaction among peer review, grants management, program, budget, and other Institute and/or Centers (IC) staff. These levels are based on allowable costs that are consistent with the principles of sound cost management and in consideration of IC priorities, constraints on the growth of average grant costs, and the availability of funds.
Before considering and/or preparing an application to the SBIR & STTR programs, all applicants are strongly encouraged to review the agencies’ and NIH Institutes’ and Centers’ websites and to contact the SBIR-STTR program coordinators listed in the Omnibus Solicitation.
Trans-NIH Research Programs
Phase IIB Competing Renewal Awards
Some NIH Institutes/Centers (ICs) offer Phase II SBIR/STTR awardees the opportunity to apply for Phase IIBCompeting Renewal awards. These are available for those projects that require extraordinary time and effort in the R&D phase and may or may not require FDA approval for the development of such projects, including drugs, devices, vaccines, therapeutics, and medical implants related to the mission of the IC. Some ICs have announced this opportunity through the NIH Guide for Grants and Contracts (see link below), and some are using this Omnibus SBIR/STTR Grant Solicitation. Only those small business concerns who have been awarded a Phase II are eligible to apply for a Phase IIBCompeting Renewal award. Prospective applicants are strongly encouraged to contact NIH staff prior to submission. Additional requirements and instructions (e.g., submission of a letter of intent) are available in the specific IC research topics section and in the specific IC Program Funding Opportunity Announcements ( The following NIH ICs will accept applications for Phase IIBCompeting Renewal awards: NIA, NIAAA, NIAID(SBIR only),NICHD(SBIR onlyand only Competing Renewals of NICHD-supported Phase II awards), NIDA, NIDCD, NIDDK(only Competing Renewals of NIDDK-supported Phase II awards), NEI (SBIR only), NIGMS (SBIR only),NIMH (SBIR only), NCATS(SBIR only and only Competing Renewals of NCATS-supported Phase II awards), and ORIP (SBIR only).NCI offers Phase IIB opportunities that focus on the commercialization of SBIR-developed technologies. Contact the NCI SBIR Development Center at 301-594-7709, for additional information. NHLBI offers Phase IIB Competing Renewals that focus on the commercialization of technologies requiring regulatory approval through the NHLBIPhase IIB Bridge Awards (RFA-HL-16-009, and the Phase IIB Small Market Awards (RFA-HL-14-012, Contact Jennifer C. Shieh, Ph.D., at for additional information.NINDS accepts Phase IIB SBIR/STTR Competing Renewal applications through specific opportunities that focus on the commercialization of SBIR and STTR developed technologies. These opportunities can be found on the NINDSFunding Opportunities webpage: Stephanie Fertig, M.B.A., at for additional information.